CR 19-132 Rule Text

Summary of, and comparison with, existing or proposed federal regulation: None

Summary of public comments received on statement of scope and a description of how and to what extent those comments and feedback were taken into account in drafting the proposed rule: N/A

Comparison with rules in adjacent states:

Illinois: Illinois does not have rules related to laboratory work authorizations. Illinois does not require a permit for minimal sedation. Moderate sedation requires a Permit A. To receive a Permit A, a dentist must complete an anesthesiology training program that includes 75 hours of didactic and clinical study in moderate sedation (conscious sedation), physical evaluation, venipuncture, advanced airway management, technical administration, recognition and management of complications and emergencies, and monitoring with additionally supervised experience in providing moderate sedation to 20 patients. The following personnel are required to remain in the treatment room for moderate sedation: the dentist who holds the Permit A; a dental hygienist or dental assistant who has completed training; and one additional hygienist or dental assistant. Deep sedation or general anesthesia requires a Permit B. To receive a Permit B, a dentist must be a diplomate of the American board of Oral and Maxillofacial Surgery, or complete 2 years of advanced training in anesthesiology or have a specialty license in oral and maxillofacial surgery. The following equipment is required: sphygmomanometer; stethoscope; oxygen delivery system; emergency drugs; suction equipment; emergency backup lighting system; pulse oximeter; laryngoscope; advanced airway devices; tonsillar or pharyngeal suction tips; nasal and oral airways; defibrillator; equipment for the establishment of an intravenous infusion; operating chair or table; and recovery area with available oxygen, lighting, suction and electrical outlets. Adverse reactions are required to be reported to the Board. Nine hours of continuing education is required per renewal cycle.

Iowa: Iowa does not have rules related to laboratory work authorizations Iowa requires a moderate sedation permit or general anesthesia permit if the dentist is doing moderate sedation, deep sedation or general anesthesia. To qualify for a moderate sedation permit, the applicant shall complete a training program approved by the board that consists of a minimum of 60 hours of instruction and management of at least 20 patients or an accredited residency program that includes: formal training and clinical experiences in moderate sedation; a training that includes rescuing patients from a deeper level of sedation than intended; and if intends to utilize on pediatric or ASA III or IV patients, an accredited residency program that includes formal training in anesthesia and clinical experience in managing pediatric or ASA III or IV patients. To qualify for a general anesthesia permit, the applicant shall compete an advanced education program accredited by the Commission on Dental Accreditation that provides training in deep sedation and general anesthesia; a minimum of one year of advanced training in anesthesiology and related academic subjects in a training program approved by the anesthesia credentials committee of the board; formal training in airway management; and current ACLS certification. The dentist must evaluate a patient prior to the start of any sedative procedure. The dentist must not leave the facility until the patient meets the criteria for discharge and the dentist or another designated permit holder or licensed sedation provider must be available for postoperative aftercare for a minimum of 48 hours following the administration of sedation. A dentist who administers moderate sedation, deep sedation or general anesthesia is required to have the following equipment: electrocardiogram monitor; positive pressure oxygen; suction; laryngoscope and blades; endotracheal tubes; magill forceps; oral airways; stethoscope; blood pressure monitoring device; pulse oximeter; emergency drugs; defibrillator; capnography machine to monitor end-tidal carbon dioxide; pretracheal or precordial stethoscope; and any additional equipment necessary to establish intravascular or intraosseous access. Dentists must report any adverse occurrence related to sedation or nitrous oxide within a period of 7 days. Permits expire every 2 years.

Michigan: Michigan does not have rules related to laboratory work authorizations Michigan adopts the standards for advanced training in anesthesia and pain control and training in intravenous conscious sedation and related subjects set forth by the Commission on Dental Education of the American Dental Association in the publication entitled “Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students” (October 2012). Michigan adopts the standards for enteral sedation course as outlined in the Dental Education of the American Dental Association in the publication entitled “Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students” (October 2012). Michigan adopts the standards regarding the equipment within a facility set forth by the American Association of Oral and Maxillofacial Surgeons in the publication entitled “Office Anesthesia Evaluation Manual” (8th edition). Dentists must report morbidity reports within 30 days after the incident and mortality report within 5 days after the incident.

Minnesota: Minnesota does not have rules related to laboratory work authorizations Minnesota requires the following education for deep sedation or general anesthesia: a didactic and clinical program at a dental school, hospital, or graduate medical or dental program accredited by the Commission on Dental Accreditation equivalent to a program for advanced specialty education in oral and maxillofacial surgery or a one year residency in general anesthesia at an institution certified by the American Society of Anesthesiology, the American Medical Association, or the Joint Commission on Hospital Accreditation consisting of a minimum of 390 hours of didactic study, 1, 040 hours of clinical anesthesiology and 260 cases of administration of general anesthesia to an ambulatory outpatient. The dentist has ACLS or PALS certification and CPR certification. Minnesota requires the following education for moderate sedation: a course consisting of a minimum of 60 hours of didactic education in both enteral and parenteral administration, personally administering and managing at least 10 individual supervised cases of parenteral moderate sedation (5 may be on a simulated manikin); ACLS or PALS certification and CPR certification. A dentist who is administering general anesthesia, deep sedation, or moderate sedation, or is administering nitrous oxide inhalation analgesia shall inform the board of that fact on forms provided by the board. A dentist who has a current license to practice dentistry in Minnesota may administer minimal sedation or analgesia. Adverse incidents must be reported to the board. Dentists administering general anesthesia, deep sedation, or moderate sedation need the following equipment: defibrillator; positive pressure oxygen delivery system; suction device; auxiliary lighting; a gas storage facility; recovery area; a method to monitor respiratory function; and board approved emergency cart or kit.

Summary of factual data and analytical methodologies: The Dentistry Examining Board conducted a comprehensive review of chapters DE 9 and 11 to ensure the chapters are statutorily compliant, current with professional standards and practices and removed obsolete or unnecessary provisions. The Dentistry Examining Board reviewed the American Dental Association Guidelines for the Use of Sedation and General Anesthesia by Dentists (October 2016) and other state requirements.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:

Fiscal Estimate and Economic Impact Analysis:

The Fiscal Estimate and Economic Impact Analysis is attached.

Effect on small business:

These proposed rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats. The Department’s Regulatory Review Coordinator may be contacted by email at [e-mail], or by calling [phone].

Agency contact person:

Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, Wisconsin 53708; telephone [phone]; email at [e-mail].

Place where comments are to be submitted and deadline for submission:

Comments may be submitted to Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, Madison, WI 53708-8366, or by email to [e-mail]. Comments must be received at or before the public hearing to be held on November 6, 2019 to be included in the record of rule-making proceedings.

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TEXT OF RULE

Section 1. DE 9.015 (2) is amended to read:

DE 9.015 (2) “Work authorization” means an official, signed request to a dental workroom or laboratory from a licensed dentist that clearly and thoroughly transmits at least the date of request, the doctor’s name, license number, and contact information, the patient information, choice of base material, choice of metal alloy or type of porcelain to be used for the prosthesis, choice of margin and pontic design of the prosthesis, impressions or measurements, and shade description.

Section 2. DE 9.02 is repealed and recreated to read:

DE 9.02 Work authorizations. Work authorizations shall include all of the following:

(1) The patient’s name or identification number.

(2) The dentist’s name.

(3) Prescription information.

Section 3. DE 11.02 (1) is repealed.

Section 4. DE 11.02 (1g) is created to read:

DE 11.02 (1g) “ASA” means American Society of Anesthesiologists.

Section 5. DE 11.02 (1m) is repealed.

Section 6. DE 11.02 (1s), (1t) and (1u) are amended to read:

DE 11.02 (1s) “Class I permit" means a sedation permit enabling a dentist to administer oral conscious sedation-enteral issued prior to [LRB insert effective date]. This permit is no longer valid.

(1t) “Class II permit" means a sedation permit enabling a dentist to administer conscious sedation-parenteral and conscious sedation-enteral moderate sedation.

(1u) “Class III permit" means a sedation permit enabling a dentist to administer moderate or deep sedation, or general anesthesia, conscious sedation-parenteral, and conscious sedation-enteral.

Section 7. DE 11.02 (2) is repealed.

Section 8. DE 11.02 (2g) and (2r) are created to read:

DE 11.02 (2g) “Continual” means repeated regularly and frequently in a steady succession.

(2r) “Continuous” means prolonged without any interruption at any time.

Section 9. DE 11.02 (3) is amended to read:

DE 11.02 (3) “Deep sedation" means a controlled state drug-induced depression of depressed consciousness, accompanied by partial loss of protective reflexes, including the ability to independently and continuously maintain an airway and to respond purposefully to verbal command, produced by during which a pharmacologic patient cannot be easily aroused but respond purposefully following repeated or non-pharmacologic method, or a combination of pharmacologic and non-pharmacologic methods painful stimulation. The ability to independently maintain ventilatory function may be impaired. A patient may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function in usually maintained.

Section 10. DE 11.02 (3m) is created to read:

DE 11.02 (3m) “Enteral” means administration by which the agent is absorbed through the gastrointestinal tract or through the oral, rectal, or nasal mucosa.

Section 11. DE 11.02 (4) is amended to read:

DE 11.02 (4) “General anesthesia" means a controlled state of unconsciousness accompanied by partial or complete drug-induced loss of protective reflexes, including the ability to independently maintain an airway and respond purposefully to physical stimulation or verbal command, produced by consciousness during which a pharmacologic or non-pharmacologic method, or a combination of pharmacologic and non-pharmacologic methods patient is not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. A patient often requires assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.

Section 12. DE 11.02 (4e) (4m) and (4s) are created to read:

DE 11.02 (4e) “Immediately available” means physically located in the dental office or facility and ready for immediate use or response.

(4m) “Minimal sedation” means a minimally depressed level of consciousness, produced by a pharmacological method that retains the patient’s ability to independently and continuously maintain an airway and respond normally to tactile stimulation and verbal command. Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected.

(4s) “Moderate sedation” means a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. If more than one enteral drug is administered or if an enteral drug is administered at a dosage that exceeds the maximum recommended dose during a single appointment, such administration is considered moderate sedation.

Section 13. DE 11.02 (6) is amended to read: